Clinical trials

Pediatric acute respiratory distress syndrome (ARDS) is a life-threatening clinical syndrome, and dyspnea is its key symptom. Strenuous respiratory effort is a "second hit" for ARDS lungs, inducing changes in regional lung aeration and amplifying lung damage in preclinical studies, a phenomenon known as "patient self-inflicted lung injury". In a clinical setting, clinicians are concerned about the possible connection between dyspnea and ARDS progression based on indirect evidence, such as the worse outcomes associated with delayed intubation or failed weaning from mechanical ventilation. Dyspnea is hard to quantify due to its subjective nature. Still, it can be assessed through its interrelated and independent components: respiratory drive (neural stimuli), respiratory effort (muscle contraction), and work of breathing (energy expenditure). This project aims to identify mechanical thresholds of dyspnea components to predict early ARDS progression and outcome. The role of respiratory effort is particularly relevant in three phases of ARDS where a transition between spontaneous and controlled ventilation occurs: 1) acute phase, when we try to prevent mechanical ventilation (MV) through non-invasive support; 2) intermediate phase, transitioning from controlled to assisted MV; and 3) late phase, during weaning from MV. These transitions are challenging because it is difficult for clinicians to titrate adequate support and avoid both under- and over-assistance. In critically ill children, there are no established thresholds for dyspnea components that predict ARDS progression, and it remains unknown whether regional changes in lung aeration can anticipate this clinical deterioration. This is particularly relevant because the oxygenation decline signals that ARDS progression has already occurred, leading to a less reversible condition. We will use and integrate advanced respiratory monitoring tools to quantify these components, including surface electromyography, occlusion maneuvers, and esophageal manometry. Additionally, electrical impedance tomography, recently adapted for pediatric use, will be employed to detect early changes in regional aeration. All tools used are gold standards for each parameter and allow real-time, bedside measurements without adding invasiveness to usual care. To test our hypothesis, we will quantify respiratory drive, effort, work of breathing, and regional lung aeration throughout all transitional phases of pediatric ARDS. In the acute phase, drive will be assessed via spectral analysis of surface electromyography, and in intermediate and late phases, via airway occlusion pressure at 100 ms. Esophageal manometry will be used to measure effort (swings of esophageal pressure) and work of breathing (pressure-time product). Changes in regional aeration (overstretching, collapse, and heterogeneity) will be assessed using electrical impedance tomography. We will define mechanical thresholds and cut-off points for each dyspnea component that predict early ARDS progression and outcomes at each transitional phase. Based on the study results, we envision the future development of algorithms to help guide safer transitions between spontaneous and controlled ventilation, to improve outcomes, and prevent residual morbidity. Our interdisciplinary team of clinicians and biomedical engineers will work to customize respiratory care in critically ill children, optimizing ventilatory assistance across disease stages.

Heart failure is frequently associated with inspiratory muscle weakness, which contributes to dyspnea, reduced exercise capacity, impaired quality of life, and adverse cardiovascular outcomes. Although inspiratory muscle training (IMT) is a recommended adjunct to cardiovascular rehabilitation, the optimal training modality remains uncertain, particularly among patients with reduced and preserved ejection fraction. This randomized controlled trial will evaluate the efficacy of a novel inspiratory muscle training protocol using tapered flow resistive loading (TFRL) compared with conventional threshold loading (TL) and usual care. A total of 108 clinically stable patients with heart failure (NYHA class II-III) will be enrolled. Participants will be stratified according to heart failure phenotype (reduced or preserved ejection fraction) and allocated to one of three groups: TFRL, TL, or control. Both training interventions will be performed for 8 weeks in combination with supervised exercise-based cardiac rehabilitation. Primary and secondary outcomes will include inspiratory muscle strength and endurance, exercise capacity, pulmonary function, dyspnea, skeletal muscle oxygenation, autonomic balance, arterial stiffness, and health-related quality of life. The study is powered to detect moderate between-group differences and interaction effects with 80% statistical power and a two-sided alpha level of 0.05. Changes over time and between groups will be analyzed using analysis of covariance (ANCOVA), adjusting for baseline inspiratory muscle strength. The trial aims to determine whether TFRL provides superior clinical and physiological benefits compared with conventional inspiratory muscle training and whether treatment responses differ according to heart failure phenotype.

This randomized controlled trial aims to compare the effects of contralateral eccentric and concentric resistance training performed during the immobilization period following acromioclavicular joint injury. Immobilization is commonly prescribed after injury but may lead to reductions in muscle mass, neuromuscular function, force production, and upper-limb functionality. Contralateral resistance training, also known as cross-education training, involves exercising the non-injured limb to induce beneficial adaptations in the immobilized limb through neural mechanisms. While both eccentric and concentric exercise may produce contralateral effects, their relative effectiveness in a clinical population remains unclear. Participants with acute acromioclavicular joint injury requiring sling immobilization will be randomly assigned to either a contralateral eccentric training group or a contralateral concentric training group. During immobilization, participants will perform supervised resistance training with the non-injured upper limb. Following immobilization, all participants will receive the same standardized rehabilitation program. Neuromuscular function, muscle morphology, force production, upper-limb function, and quality of life will be assessed before immobilization, after immobilization, and following rehabilitation. The findings may contribute to the development of more effective rehabilitation strategies for patients recovering from upper-limb injuries requiring temporary immobilization.

Exercise is recommended for people with fibromyalgia because it can reduce symptoms and improve quality of life. Some studies show that high-intensity exercises like running or cycling (also called high-intensity interval training, or HIIT) may reduce symptoms more effectively than slower, traditional exercises. There are also new treatments, like non-invasive neuromodulation, which uses a gentle current to stimulate brain cells. This technique can help reduce pain in people with fibromyalgia. However, we don't yet know if combining HIIT and neuromodulation works better than exercise alone. We also want to find out if this combination helps improve other symptoms like fatigue and poor sleep. The goal of this study is to see how a combination of HIIT and neuromodulation affects pain, fatigue, sleep, and muscle strength in women with fibromyalgia. The investigators are asking two main questions: Does combining HIIT and neuromodulation reduce pain better than exercise alone? Does this combination improve how the brain controls pain, muscles, and other symptoms like fatigue and sleep problems? What Will the Study Involve? Three different exercise training programs will be compared: HIIT with neuromodulation (tDCS): The participant will do HIIT by cycling at a high intensity for 1 minute, then resting for 2 minutes. Then, this will be repeated 10 times. At the same time, the researchers will place two small, damp sponges on the head of the participant. These sponges connect to the tDCS device, which sends a gentle current to your brain. It might feel a tingling sensation at first, but it will fade away. HIIT with a "sham" (inactive) neuromodulation: This is similar to the first program, but the tDCS device will only be active for a few minutes at the beginning and end of the session. HIIT alone: This involves just the cycling exercise with no brain stimulation. Who Can Participate? The researchers are looking for women who: Are 18-65 years old and have been diagnosed with fibromyalgia Experience moderate to high levels of pain Have stable blood pressure (if they have hypertension) Are not regularly active (don't do more than 30 minutes of exercise at least 3 times per week) What Will the Study involve? The participant will: Attend 6 conditioning sessions (cycling) over two weeks to prepare their body. Complete 4 weeks of HIIT training, three times per week, at Universidad Andres Bello. Attend 3 assessment sessions in our lab: before the conditioning, before the training, and after the training. These will include: Non-invasive tests to measure your physical fitness, muscle strength, and pain sensitivity Brain and muscle connection tests. Questionnaires about your sleep, pain, fatigue, anxiety, depression, and exercise enjoyment What the participant will get? At the end of the study in addition to the training benefits, participants will receive a detailed report showing their body composition (muscle and fat levels) before and after the training.

The randomized controlled trial will compare the effects of a High-intensity interval training (HIIT) protocol versus a HIIT plus plyometric training in the muscle-tendon structure function and metabolism of the pediatric population with obesity at different biological maturational stages (pre-to-age peak velocity \[APHV\] and post-APHV). Both groups perform baseline evaluations of the main and secondary outcomes and receive the intervention for twelve weeks, three times per week. Once the interventions are completed, the participants undergo the same evaluations they performed at baseline.

This study evaluates a diagnostic support platform, DIAGEN-IA, designed to identify pediatric neurological diseases with a genetic basis. Conducted at Carlos Van Buren Hospital in Chile, it aims to determine if the platform reduces inappropriate referrals to clinical geneticists, improves diagnostic evaluations, enhances referral quality, and increases user satisfaction. A prospective before-and-after design will compare outcomes across two phases: baseline data collection and an intervention phase using DIAGEN-IA. Healthcare professionals will use the platform to guide referrals and diagnostic studies. Outcomes include referral appropriateness, completeness of evaluations, quality of referrals, and user satisfaction.

This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.